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ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[iU] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 10000[iU] in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g
Labeler: Neopharm Co., Ltd.
NDC Code: 51141-0238

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF

ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF

Active Ingredients (each gram contains)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5mg

Polymycin B Sulfate 10,000 units

Pramoxine HCl 10mg

Purpose



First Aid Antibiotic
Topical Analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain and discomfort of minor cuts, scrapes, burns.

Warnings

For external use only

Do not use
  • if you are allergic to any of the ingredients
  • in or near the eyes
  • longer than 1 week
  • over large areas of the body

Ask a doctor before use
  • on deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if
  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older

  • clean the affected area and dry throughly
  • apply a small amount (equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 yrs. of age

  • Consult a doctor.

Other Information
  • store at 68° – 77°F (20° – 25°C)
  • see carton flap or tube crimp for lot number and expiration date

Inactive Ingredients

PETROLATUM, LIGHT MINERAL OIL, STEARIC ACID, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHMIDE MEA.

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ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF  
bacitracin zinc, neomycin sulfate, polymycin b sulfate, pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0238
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN500 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B10000 [iU]  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
LIGHT MINERAL OIL 
CHOLESTEROL 
STEARIC ACID 
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA 
Packaging
#Item CodePackage Description
1NDC:51141-0238-11 TUBE in 1 CARTON
128.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/08/2012
Labeler - Neopharm Co., Ltd. (965502912)
Establishment
NameAddressID/FEIOperations
NeoPharm Co., Ltd.631101883manufacture(51141-0238)

Revised: 06/2015
 
Neopharm Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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